FDA UDI
In Commercial Distribution
🇺🇸 United States
SancDam™
DI: 09555514011420
·
Model: OD001-S62-P103
·
SANCTUARY HEALTH SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- SancDam™
- Primary DI
- 09555514011420
- Version / Model
- OD001-S62-P103
- Company Name
- SANCTUARY HEALTH SDN. BHD.
- Labeler DUNS
- 534420066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-10-20
- Public Version
- 1
- Public Version Date
- 2023-10-30
- Public Version Status
- New
- Public Device Record Key
- b626f8c0-0136-4226-81c6-b00720ad474d
Device Description
Mixed of 4 flavours of Vanilla, Grape, Strawberry and Mint. Assorted pack of 4 boxes. Used as barrier when engaging in oral/vaginal and oral/anal sex against sexually transmitted diseases
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSC | Barrier, Std, Oral Sex | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47729 | Oral/vaginal sex barrier, Hevea-latex | A device in the form of a flat sheet (a rubber dam), composed of Hevea-latex, designed to help reduce the risk of catching/spreading sexually transmitted infections (STI), also known as sexually transmitted diseases (STD), such as syphilis, gonorrhoea, Chlamydia infections, genital herpes, and acquired immune deficiency syndrome (AIDS ) during oral-vaginal sexual activity. It is placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the entire anal area, including the anus. It is held in place by one of the sexual partners and may be moistened with a commercially available lubricant to enhance performance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 19555514011427 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 09555514011420 | GS1 | ||||
| Unit of Use | 29555514011424 | GS1 |